AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)
1 other identifier
interventional
725
1 country
52
Brief Summary
The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2008
Shorter than P25 for phase_2
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 12, 2008
CompletedFirst Posted
Study publicly available on registry
December 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
May 19, 2011
CompletedJune 20, 2011
April 1, 2011
5 months
December 12, 2008
January 28, 2011
June 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.
From randomization (baseline) to week 4
Secondary Outcomes (4)
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
From randomization (baseline) to week 4
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
From baseline (randomization) to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
From baseline ( randomization) to week 4
Change in Sheehan Disability Scale (SDS) Global Total Score
From baseline ( randomization) to week 4
Study Arms (4)
A-AZD7325 2mg
EXPERIMENTALAZD7325 2mg BID
B-AZD7325 5mg
EXPERIMENTALAZD7325 5mg BID
C-AZD7325 10mg
EXPERIMENTALAZD7325 10mg QD
D-Placebo
EXPERIMENTALPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent before any study-related procedures start.
- The patient is previously diagnosed with Generalized Anxiety Disorder.
- The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.
You may not qualify if:
- Patient has a lifetime history of schizophrenia or other psychotic disorders
- Patient has a history of seizures or seizure disorder.
- Patient is pregnant or breast feeding.
- Patient has received electroconvulsive treatment (ECT) in the past.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (52)
Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Arcadia, California, United States
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Beverly Hills, California, United States
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Cerritos, California, United States
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Chino, California, United States
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Encino, California, United States
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Los Alamitos, California, United States
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Novato, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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Norwich, Connecticut, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Saint Petersberg, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Smyrna, Georgia, United States
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Libertyville, Illinois, United States
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Park Ridge, Illinois, United States
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Indianapolis, Indiana, United States
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Overland Park, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Cambridge, Massachusetts, United States
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St Louis, Missouri, United States
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Clementon, New Jersey, United States
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Fresh Meadows, New York, United States
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Mount Kisco, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Beechwood, Ohio, United States
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Cincinnati, Ohio, United States
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Middleburg Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Jenkintown, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Memphis, Tennessee, United States
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Friendswood, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Woodstock, Vermont, United States
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Herndon, Virginia, United States
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Spokane, Washington, United States
Research Site
Middleton, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Mark A. Smith, MD, PhD
AstraZeneca
- PRINCIPAL INVESTIGATOR
David V. Sheehan
University of South Florida College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 12, 2008
First Posted
December 15, 2008
Study Start
December 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
June 20, 2011
Results First Posted
May 19, 2011
Record last verified: 2011-04